FDA Adverse Event
Malfunction
Summary report: N
MAT; MECHANICAL ADVANTAGE TOURNIQUET
MDR report key: 1714753
·
Received June 2, 2010
Report
- Report Number
- 9615387-2010-00005
- Event Type
- Malfunction
- Date Received
- June 2, 2010
- Date of Event
- May 12, 2010
- Report Date
- June 2, 2010
- Manufacturer
- PYNG MEDICAL CORP.
- Product Code
- GAX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO PYNG MEDICAL.
Description of Event or Problem · 1
DURING A TRAINING SESSION THE BUCKLE LOCKING THE STRAP INTO PLACE SLIPPED CAUSING THE DEVICE TO NOT STAY TIGHT AROUND THE ARM. NO PT WAS INVOLVED. PYNG (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAT; MECHANICAL ADVANTAGE TOURNIQUET | TOURNIQUET, NONPNEUMATIC | GAX | PYNG MEDICAL CORP. | MAT | 933 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |